NeuroOne Medical Technologies Corporation - NMTC STOCK NEWS

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the successful completion of an animal feasibility study for its OneRF™ ablation system, which uses existing sEEG diagnostic electrodes for brain lesioning. The study, guided by Dr. Jamie Van Gompel at the Mayo Clinic, confirmed successful RF ablations that may improve procedure safety. The company plans to submit a 510(k) application for FDA clearance in Q2 2023. Additionally, NeuroOne is advancing therapeutic electrode technologies targeting markets worth $500 million to $6 billion.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announced the shipment of its first commercial order of Evo sEEG Electrode technology to Zimmer Biomet, its exclusive global distribution partner. This marks a significant milestone for the company, as the Evo sEEG System is its second FDA 510(k) cleared product, targeting a $100 million market for brain mapping procedures. NeuroOne is also developing additional therapeutic electrode technologies for chronic conditions, with potential market values between $500 million and $6 billion.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announced it will ring the Nasdaq closing bell on November 22, 2022, to celebrate its recent FDA 510(k) clearance for the Evo sEEG Electrode technology. This milestone supports commercialization efforts and enhances the functionality of the Evo sEEG System, designed for temporary brain signal monitoring and stimulation. CEO Dave Rosa expressed excitement over this achievement at the iconic ceremony, broadcast live from Times Square, New York City, at 4:00 p.m. ET.

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) has received FDA 510(k) clearance for its Evo sEEG Electrode technology. This allows for temporary use (less than 30 days) in recording and stimulating electrical signals in the brain. The Evo system is significantly less invasive than traditional cortical electrodes, addressing a $100 million market for diagnostic brain mapping. NeuroOne plans to advance commercialization in partnership with Zimmer Biomet, and is also developing therapeutic electrode technologies targeting markets valued up to $6 billion.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announced on September 22, 2022, the approval of equity awards to new employees as part of the 2021 Inducement Plan. Effective September 20, 2022, these individuals were granted options to purchase 1,000 shares at an exercise price of $1.97, based on the closing stock price on the grant date. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly after that, contingent on continuing employment.

NeuroOne Medical Technologies (NASDAQ: NMTC) reported its third-quarter fiscal 2022 results, highlighting a net loss of $2.8M, a slight decrease from $3.0M in Q3 2021. Product revenue fell to $32,000 from $40,000 year-over-year, while collaboration revenue was impacted by FDA delays. Operating expenses decreased to $2.8M compared to $3.0M in the prior year. The company secured a $3.5M milestone payment from Zimmer Biomet for the Evo® sEEG electrode and made significant progress in product testing and FDA submissions.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) has re-submitted a special 510(k) application to the FDA on August 8, 2022, to extend the usage duration of its sEEG electrode from less than 24 hours to less than 30 days. This expedited review is expected to be completed within 30 days. Following a previous setback in May, where the FDA upheld a decision of not substantially equivalent, NeuroOne has addressed biocompatibility concerns. CEO Dave Rosa expressed optimism about the submission and continued discussions with the FDA.

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) will hold a conference call on August 11, 2022, at 5:30 PM Eastern Time to discuss its financial results for the third quarter of fiscal 2022, which ended on June 30, 2022. This call will provide insights into the company's performance and strategic direction in developing minimally invasive solutions for neurological disorders.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announced an amendment to its agreement with Zimmer Biomet, securing a $3.5 million accelerated payment related to milestone achievements. In return, Zimmer will receive 350,000 warrants with an exercise price of $3.00 per share. This funding will bolster NeuroOne's balance sheet while avoiding highly dilutive financing. CEO Dave Rosa expressed gratitude for Zimmer's support, highlighting the strategic partnership established since July 2020, which allows Zimmer exclusive distribution rights for NeuroOne's technology.